Skip to main content
OpenTrials
Completed

NCT Number: NCT00345800

Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes

To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Narcolepsy With Cataplexy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Liège, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

  • Narcoleptic patients with cataplexy

Exclusion criteria

  • Subjects not diagnosed with narcolepsy with cataplexy

Exclusion criteria

Treatment and study plan

Sodium Oxybate (Xyrem)

Drug
  • Active Substance: Sodium Oxybate
  • Pharmaceutical form: Oral Solution
  • Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
  • Route of administration: Oral

Other names: Xyrem

Primary outcomes

  1. The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.

  2. The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)

    Time frame: After 1 month of treatment (Visit 3)

    An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.

  3. The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)

    Time frame: After 3 months of treatment (Visit 4)

    An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.

Secondary outcomes

  1. The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH.

  2. The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH.

  3. The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH.

  4. Cortisol Measured at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol.

  5. Cortisol Measured at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol.

  6. Cortisol Measured at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol.

  7. The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2.

  8. The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3.

  9. The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4.

  10. The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2.

  11. The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3.

  12. The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4.

  13. The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2.

  14. The Prolactin Measured in Fasting Conditions at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.

  15. The Prolactin Measured in Fasting Conditions at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.

  16. The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2.

  17. The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3.

  18. The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4.

  19. The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2.

  20. The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3.

  21. The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4.

  22. The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2.

  23. The Osmolality Measured in Fasting Conditions at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.

  24. The Osmolality Measured in Fasting Conditions at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.

  25. Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.

  26. The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)

    Time frame: Baseline (Visit 2) - approximately 1 day

    An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.

  27. Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.

  28. The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3

    Time frame: Visit 3 (approximately 1 month)

    An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.

  29. Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.

  30. The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4

    Time frame: Visit 4 (approximately 3 months)

    An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.

  31. The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study

    Time frame: Visit 1 through the end of the study (approximately 4 months)

    An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with at least one TEAE is reported below.

  32. The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study

    Time frame: Visit 1 through the end of the study (approximately 4 months)

    An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with TEAE that led to temporarily discontinuation of study drug is reported below.

  33. The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study

    Time frame: Visit 1 through the end of the study (approximately 4 months)

    A Serious Adverse Event is any untoward medical occurrence that at any dose • results in death, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect

Sponsors and collaborators

Lead sponsor

UCB Pharma SA

Industry

Registry information

Official study title

Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 29, 2006
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.